The following data is part of a premarket notification filed by Jubilee Scooters, Inc. with the FDA for California Comfort Four Wheel.
Device ID | K895384 |
510k Number | K895384 |
Device Name: | CALIFORNIA COMFORT FOUR WHEEL |
Classification | Wheelchair, Special Grade |
Applicant | JUBILEE SCOOTERS, INC. 324 LAKESIDE DR. SUITE A Foster City, CA 94404 |
Contact | Ray Drieger |
Correspondent | Ray Drieger JUBILEE SCOOTERS, INC. 324 LAKESIDE DR. SUITE A Foster City, CA 94404 |
Product Code | IQC |
CFR Regulation Number | 890.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-30 |
Decision Date | 1989-09-18 |